Kornimate/medical-research-clean huggingface dataset:
the safety of vardenafil in patients undergoing cardiac surgery

Conditions: Ischemia-reperfusion Injury.

Summary: the purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.


Eligibility criteria:
inclusion criteria: * undergoing cardiac surgery exclusion criteria: * emergent surgery * recent mi in past 7 days prior to surgery * ejection fraction \< 35% * creatinine \> 2.0 * prior cva * severe copd * recent use of nitrates (within past 48 hours prior to surgery) * prior cabg * pregnancy
ovarian endometrioma ablation using plasma energy versus cystectomy

Conditions: Ovarian Endometrioma

Summary: objective: to compare loss of ovarian parenchyma following ovarian endometrioma ablation using the plasmajet system versus cystectomy, using postoperative examination by 3d ultrasound. design: prospective comparative study. setting: two experienced surgeons practicing in two university tertiary referral centers. patients: fifty women with no previous history of ovarian surgery managed for unilateral ovarian endometrioma \> 30 mm in diameter. interventions: endometrioma ablation by plasma energy using the plasmajet system and ovarian tissue sparing cystectomy. main outcome measures: 3d ultrasound assessment of postoperative reduction in ovarian volume and antral follicle count (afc) .

the management of ovarian endometriomas in women wishing to conceive remains challenging. recent data suggest that excising endometriomas by ovarian tissue sparing cystectomy does not avoid inadvertent removal of ovarian parenchyma surrounding the cyst, particularly in enlarged cysts. although several authors question whether the ovarian parenchyma immediately surrounding the cyst may still be functional, there is little doubt that postoperative fertility could be significantly impaired by loss of ovarian cortex and provokes the question as to whether pregnancy should be initiated before performing a cystectomy, whenever this scenario is possible. however ovarian surgery cannot always be delayed to the postpartum period, numerous women require endometrioma management while not seeking an immediate pregnancy and still wish to conserve their procreative capabilities. after a period of some years during which cystectomy appeared to be the best surgical technique in the treatment of ovarian endometriomas in women wishing to become pregnant, recent data have suggested that ablation of the inner layer of the endometrioma may be a valuable alternative technique, as long as the energy employed avoids thermal diffusion to surrounding ovarian tissue. the department of gynecology at the university hospital in rouen, france have introduced ablation by plasma energy using the plasmajet system (plasma surgical ltd, abingdon, uk) and have already been able to report encouraging results based on non comparative pilot studies and on retrospective "before and after" comparative study. the aim of the study is to prospectively compare loss of ovarian parenchyma and decrease in antral follicle count (afc) following ovarian endometrioma ablation using plasma energy versus cystectomy, when performed by only two expert surgeons. postoperative examination is carried out by 3d ultrasound.

Eligibility criteria:
inclusion criteria: * age between 18 and 45 years; * surgery required by pelvic pain or infertility related to endometriosis; * clinical and imaging data proving unilateral ovarian endometrioma which diameter exceeds 30 mm. exclusion criteria: * previous surgery on ovaries or ivf procedures; * bilateral endometriomas; * pregnancy * woman not french speaker.

Keywords: endometrioma endometriosis cystectomy ablation plasma energy
cabozantinib real-life use for advanced renal cell carcinoma in france: a retrospective descriptive non-interventional study of 2 cohorts.

Conditions: Renal Cell Carcinoma

Summary: the primary objective of the study is to describe the real-life conditions of use and exposure of cabozantinib in france in two cohorts defined by their treatment initiation period.


Eligibility criteria:
inclusion criteria: * any subjects from the participating sites (dead or alive) who have received at least one dose of cabozantinib within the atu program or between 10/12/2016 and 16/02/2018 and for whom the medical file is available exclusion criteria: * patients alive at study initiation who have not received information notice * who have opposed to data collection.
a randomized trial of electronic integration of care for better diabetes outcomes; the compete ii study

Conditions: Diabetes

Summary: this study will evaluate whether the use of an electronic diabetes tracker by both patients and family physicians in ontario improves diabetes outcomes, satisfaction with care and with technology and health data privacy issues. as part of the study, the investigators will be able to test whether practices that use computers perform any better than practices using paper. the investigators also will be developing the first canadian computerized chart summary for each patient that can be communicated securely in emergencies (the emergency health record) and read by all current electronic systems.


Eligibility criteria:
inclusion criteria: * adult, cognitively intact, consenting people with diabetes within enrolled practices exclusion criteria: * non-english speaking * cognitively impaired

Keywords: diabetes computerized clinical decision support shared care patient self-monitoring quality of care complex interventions composite outcomes
incidence and risk factors of central line catheter related thrombosis

Conditions: Central Line Complication

Summary: central venous catheters are frequently used for monitoring haemodynamic status and rapidly delivering fluid therapy during the peri- and postoperative periods. indwelling central venous catheters are typically used 7-14 days postoperatively for additional monitoring and treatment, but patients may develop asymptomatic catheter-related thrombosis, leading to life-threatening pulmonary embolism and death. early detection helps to avoid such complications. this prospective observational study investigated the risk factors associated with catheter-related right internal jugular vein thrombosis in pediatric patients. the study enrolled 80 pediatric patients who were scheduled to receive central venous catheter. to detect thrombus formation, doppler ultrasound examinations from the thyroid cartilage level to the supraclavicular region were used after cvc placement and on each of the following days until the catheter was removed.


Eligibility criteria:
inclusion criteria: * pediatric patients who were scheduled to catheterize central venous catheter exclusion criteria: * patients who had skin infections on the right side of the neck, making them unsuitable for placement of the catheter via the right side of the neck * patients who had blood coagulation lesions or bleeding tendencies * patients with thrombocytopenia * patients with a history of right internal jugular vein thrombosis * patients who presented right internal jugular vein thrombosis or stenosis on preoperative doppler ultrasound examination
wearable then implantable cardiac defibrillator after myocardial infarction

Conditions: Infarction, Myocardial

Summary: sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (lvef). implantable cardiac defibrillator (icd) implantation is currently recommended at three months of optimal medical treatment in patients who have had a myocardial infarction and have a lvef below 35%. this strategy indeed allows a reduction in mortality while early post-infarction implantation showed no benefit in terms of survival. however, the risk of sudden death at this period is the greatest and the temporary defibrillator vest, marketed under the name lifevest, is now indicated in the early post-infarction period in patients with lvef less than 35%. indeed, the lifevest would allow a reduction in sudden death of rhythmic origin in the first three months post-infarction. no study has yet investigated the prognostic significance of a ventricular rhythm disorder (ventricular tachycardia \[vt\] or ventricular fibrillation \[vf\]) occurring during this early and short (approximately 3 months) particular period of wearing the lifevest: is this a random event, or is it an event predictive of a rhythmic recurrence? the aim of the study is to assess the association between the occurrence of a sustained ventricular rhythm disorder in the early post-infarction period, during the period of wearing the lifevest (ventricular episodes detected, treated or not), and the risk of rhythmic recurrence at 12 months.


Eligibility criteria:
inclusion criteria: * adult patients who benefited, between the start of 2015 and january 1, 2021, from a lifevest after a myocardial infarction, followed by the implantation of an icd before march 1, 2021. exclusion criteria: * patient opposition to the use of their data.
immunotherapy with bispecific car-t cells for b-cell lymphoma, all and cll

Conditions: Leukemia; Lymphoma

Summary: this study aims to evaluate the safety, efficacy and duration of response of anti-cd19 anti-cd20 bispecific chimeric antigen receptor (car) redirected autologous t-cells in patients with high risk, relapsed cd19+ and cd20+ haematological malignancies.

this is a multi-centre, non-randomised, open label phase i clinical trial of an advanced therapy investigational medicinal product named cd19 cd20 chimeric antigen receptor (car) t-cells (cd19 car t-cells) in patients with high risk, relapsed cd19+ and cd20+haematological malignancies (leukemia and lymphoma). following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the cd19 cd20 car t-cells. patients will receive the cd19 cd20 car t-cells following lymphodepleting chemotherapy. the study will evaluate the safety, efficacy and duration of response of the cd19 cd20 car t-cells in patients with high risk relapsed cd19+ malignancies.

Eligibility criteria:
inclusion criteria: 1. relapsed or refractory b cell derived acute lymphoblastic leukemia(all), chronic lymphoblastic leukemia(cll) and non-hodgkin lymphoma. 2. kps\>60. 3. life expectancy\>3 months. 4. gender unlimited, age from 18 years to 70 years. 5. cd19 or cd20 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry. 6. patients who have failed at least one line of a standard treatment. 7. no serious mental disorder. 8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(cr≤133umol/l). 9. no other serious diseases(autoimmune disease, immunodeficiency etc.). 10. no other tumors. 11. patients volunteer to participate in the research. 12. patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active gvhd and no longer taking immunosuppressive agents for at least 30 days prior to trial. exclusion criteria: 1. kps\<50. 2. patients are allergic to cytokines. 3. central nervous system leukemia within 28 days. 4. uncontrolled active infection. 5. acute or chronic gvhd. 6. treated with t cell inhibitor. 7. pregnancy and nursing females. 8. hiv/hbv/hcv infection. 9. other situations we think improper for the research.

Keywords: leukemia lymphoma car-t bispecific cd20 cd19
artiss a single-centre randomised control study

Conditions: Breast Neoplasms; Mammaplasty

Summary: the influence of artiss on post-operative abdominal drainage and seroma formation in diep/ms-tram free flap breast reconstruction patients.

the principle aim of the study is to investigate the effect of artiss on abdominal wound drainage whether this could result in earlier drain removal and earlier patient discharge from hospital. the primary outcome investigated will be post- operative abdominal drainage duration in days which is vital information during this covid pandemic to reduce hospital stay (and therefore possible covid exposure) which could result in earlier discharge from hospital, as well as significantly reducing cost of the procedure to the nhs and frees in-patient beds for more efficient use of resources.

Eligibility criteria:
inclusion criteria: * female adult (age 18-80) * patients planned for immediate or delayed diep/ms-tram breast reconstruction exclusion criteria: * patients who are unable to consent or do not consent * clotting disorder * pregnancy * individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia). * covid positive * known previous allergic reactions to artiss

Keywords: muscle-sparing transverse rectus abdominis myocutaneous flap deep inferior epigastric artery perforator
applying moziak device compared to standard manual compression on arterio-venous fistula puncture sites haemostasis

Conditions: Post Dialysis Arterio-Venous Fistula Puncture Sites

Summary: the study aimed to evaluate the effectiveness of applying moziak device compared to standard manual compression post dialysis arterio-venous fistula puncture sites haemostasis

application of new device to find a solution for nursing challenge for caring patient post dialysis arterio-venous fistula puncture sites haemostasis

Eligibility criteria:
inclusion criteria: * all patients undergoing hemodialysis therapy * both sex exclusion criteria: * less than 18 years old * patient has central vascular access
comparison of conventionally manufactured afo and modular customized afo

Conditions: Gait, Drop Foot

Summary: the investigator will investigate the difference in the gait pattern between 2 commercially available ankle foot orthoses (afo): a) conventionally manufactured afo and b) modular customized afo using industry 4.0 technology. measurement method: the participants perform an instrumented gait analyses while overground walking at a self - selected speed using a conventionally manufactured afo or a modular customized afo.

cerebral palsy (cp) is the most common movement disorder in children \[stavsky, 2017\]. it is frequently accompanied by spasticity \[baker, 2009\]. the typical symptoms of spastic cerebral palsy are gait abnormalities such as equinus and drop foot that lead to severe impairments in daily life \[armand, 2016\]. as these symptoms will persist in adulthood, an afo is frequently required in this patient population. furthermore, other neurological diseases e.g stroke \[choo, 2021\], spinal cord injury, and peripheral nerve injury may require the daily use of an afo. ankle-foot orthoses (afo) have been suggested to improve the dynamic efficiency of the gait. in addition, a positive effects on gait kinetics and kinematics have been reported \[figueiredo, 2008\]. recently, modular customized afo are increasingly proposed as their response can be tuned to the patient's gait characteristics and/or functional maturity \[6\]. however, the evidence on this topic is still lacking and modular customized afo are not yet established in clinical routine. the aim of this study is to assess gait parameters with an instrumented gait analysis of the modular customized afo compared to conventional, untuned afo in a group of adolescents and a group of adults using for there daily activity an afo, while over ground walking at self selected speed over a distance of about 10 m.

Eligibility criteria:
inclusion criteria: participants fulfilling all of the following inclusion criteria are eligible for the study: * patients (11-18 yrs.), who need a new orthosis (visit to an orthopedic technician) * patients (18-65 yrs.), who need a new orthosis (visit to an orthopedic technician) * informed consent provided as documented by signature * confirmed diagnosis of cerebral palsy * confirmed diagnosis of spastic equinus and/ or drop foot, * gait pathologies treated with conventional afo * gross motor function classification system (gmfcs) level i or ii exclusion criteria: * other neuromuscular diseases * surgical intervention lower extremities past 12 months to improve gait pathologies * injections of botulinum toxin 6 months prior to study inclusion * inability or unwillingness to follow the procedures of the gait analysis * in women: pregnancy
to study the efficacy of therapeutic pulsed ultrasound in the treatment of vitiligo: a randomized, intra-individual, left-right comparison study

Conditions: Vitiligo

Summary: in this study, the investigators demonstrated that in vivo thg microscopy can differentiate vitiligo lesions and normal skin based the optical nature of melanin. this thg-based procedure provides a valuable tool for noninvasive determination of third-order nonlinear susceptibility of melanin within the skin. it can also provide real-time histopathology information for treatment follow-up, without performing invasive skin biopsy.

the investigators initiate this open, randomized, left-right comparative study to evaluate the efficacy of pulsed ultrasound in the treatment of vitiligo on the face or trunk. face is included in this study because vitiliginous lesions on the face has a better treatment response and causes more psychological distress on the patients than vitiligo affecting other body areas. thirty adult subjects with vitiligo affecting the face or trunk symmetrically will be recruited. after randomization, subjects will be administrated their ulrasound treatment twice a week for 24 weeks. their original topical treatment and/or phototherapy will be continued. during follow-up visits, digital photographs will be taken for evaluating the extent of residual depigmentation. in vivo harmonic microscopy and three skin biopsy specimens will be performed at the indicated time points on the depigmented, repigmented areas and surrounding normal skin.

Eligibility criteria:
inclusion criteria: 1. 20-75 years old 2. with skin type ⅲ or ⅳ 3. with vitiligo 4. can read the informed consent form 5. can continue the original treatments exclusion criteria: 1. with segmental vitiligo. 2. have joined other clinical trials

Keywords: vitiligo harmonic generation microscopy in vivo
efficacy of topical indomethacin patch over placebo in ankle sprain pain relief

Conditions: Ankle Sprain

Summary: this study will investigate the efficacy of the indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch

indomethacin is a non-steroidal anti-inflammatory drug (nsaid) which reduces pain, fever, stiffness and swelling in acute skeletal musculature injuries involving joints. however, oral indomethacin formulations predisposes for some systemic side effects. to avoid the systemic side effects of oral indomethacin, a topical indomethacin formulations have been developed and approved in some countries as an over the counter product. present study is to investigate the efficacy of the indomethacin patch in pain relief of ankle sprain in adult patients.

Eligibility criteria:
inclusion criteria: * participant with grade i or grade ii acute sprain of the lateral ankle within 24 hours before screening visit * participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is \>= 5 as measured on a 0-10 nrs rating. * participant with a peri-malleolar edema (sub-malleolar perimeter difference of \>=20mm between injured and uninjured ankle) exclusion criteria: * known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * participant who had medication that could interfere with the subject's perception of pain since experiencing ankle sprain. * pregnancy , breast feeding and substance abuse
docetaxel/epirubicin/bevacizumab as first line therapy for metastatic her2 negative breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and her2 negative breast cancer.

a phase ii trial with 142 patients demonstrated that therapy with docetaxel plus epirubicin is highly active first-line therapy for metastatic breast cancer, with acceptable toxicity profile. recently initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. this study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and her2 negative breast cancer. furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (ctcs) in this population.

Eligibility criteria:
inclusion criteria: * histologically- or cytologically- confirmed metastatic breast adenocarcinoma * no her2 overexpression or gene amplification * no previous therapy for metastatic breast cancer is allowed * age 18-75 years * at least 12 months interval since prior adjuvant therapy with taxanes and/or anthracyclines * measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) * performance status (who) 0-2 * adequate liver (serum bilirubin \<1.5 times the upper normal limit, ast and alt \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the unl in the presence of liver metastases) * adequate renal function (serum creatinine \<1.5 times the upper normal limit * adequate bone marrow function (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) * written informed consent exclusion criteria: * active infection * brain metastases * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * history of stroke * anticoagulation therapy (except of low dose aspirin \<325mg) * other invasive malignancy except nonmelanoma skin cancer * psychiatric illness or social situation that would preclude study compliance * pregnant or lactating women

Keywords: breast cancer chemotherapy biological therapy
mathematical modeling analysis of serum prostate specific antigen after radiotherapy

Conditions: Prostate Cancer

Summary: clinical data are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer.

clinical data (prostate-specific antigen \[psa\] response after radiotherapy) are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer.

Eligibility criteria:
inclusion criteria: * prostate cancer treated with radiotherapy +/- hormones exclusion criteria: * prostatectomy

Keywords: prostate cancer prostate specific antigen radiotherapy mathematical modeling
insulin treatment in cancer cachexia

Conditions: Cancer Cachexia

Summary: the study is designed to evaluate whether daily insulin treatment to weight losing cancer patients attenuates progression of cancer cachexia and improves metabolism.

randomized study with long-term follow-up based on survival, health related quality of life, food intake, resting energy expenditure, body composition, exercise capacity and measurement of metabolic efficiency.

Eligibility criteria:
inclusion criteria: * weight loss * systemic solid cancer exclusion criteria: * diabetes * brain metastases * expectant survival of less than 6 months * serum creatinine above 200 umol/l * persistent of recurrent fever * cholestasis

Keywords: cancer cachexia tumor host metabolism